Cleared Traditional

K955690 - AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3

K955690 is an FDA 510(k) clearance for AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, manufactured by Clinical Controls, Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K955690 · Clinical Controls, Inc. · Chemistry device
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Apr 1996
Decision
132d
Days
Class 1
Risk

K955690 is an FDA 510(k) clearance for the AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on April 24, 1996 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Controls, Inc. devices

FDA 510(k) Submission Details - K955690

510(k) Number K955690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date April 24, 1996
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 569
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K955690.
DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
K962630 · Casco Standards · Jul 1996
CHEM-CHEX STAT
K961195 · Streck Laboratories, Inc. · May 1996
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
K961293 · Consolidated Technologies, Inc. · May 1996
SERUM VOLATILES CONTROL LEVEL 1 & 2
K955691 · Clinical Controls, Inc. · Apr 1996
IMMUNOLOGY CONTROL
K960824 · Medical Analysis Systems, Inc. · Apr 1996
LIPID CONTROL
K960862 · Medical Analysis Systems, Inc. · Apr 1996